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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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35 rows where docket_id = "FDA-1977-N-0013" sorted by posted_date descending

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id agency_id docket_id title document_type subtype posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-1977-N-0013-0048 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Citizen Petition from GlaxoSmithKline Consumer Healthcare (GSKCH) Other Citizen Petition 2017-07-17T04:00:00Z 2017 7 2017-07-17T04:00:00Z   2024-11-12T05:15:25Z   1 0 09000064813341f7
FDA-1977-N-0013-0047 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 McNeil Consumer Healthcare - Letter Other Letter(s) 2012-01-26T05:00:00Z 2012 1 2012-01-26T05:00:00Z   2012-01-26T15:07:32Z   0 0 0900006480fa55cd
FDA-1977-N-0013-0046 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Interim Response to GlaxoSmithKline Consumer Healthcare - Letter Other Letter(s) 2011-07-21T04:00:00Z 2011 7 2011-07-21T04:00:00Z   2011-07-21T12:31:43Z   0 0 0900006480ec80bf
FDA-1977-N-0013-0042 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Citizen Petition from GlaxoSmithKline Consumer Healthcare Other Citizen Petition 2011-03-24T04:00:00Z 2011 3 2011-03-24T04:00:00Z   2019-02-05T12:47:52Z   0 0 0900006480c0c71c
FDA-1977-N-0013-0044 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Attachment 2 - Synopsis Report, Study Number A4000685 re: Citizen Petition from GlaxoSmithKline Consumer Healthcare Supporting & Related Material Background Material 2011-03-24T04:00:00Z 2011 3     2019-02-06T16:43:39Z   0 0 0900006480c0c908
FDA-1977-N-0013-0045 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Acknowledgment Letter from FDA DDM to GlaxoSmithKline Consumer Healthcare Other Acknowledgement Letter/Receipt 2011-03-24T04:00:00Z 2011 3 2011-03-24T04:00:00Z   2019-02-05T13:13:02Z   0 0 0900006480c0c93a
FDA-1977-N-0013-0043 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Attachment 1 - Synopsis Report, Study Number A4000684 re: Citizen Petition from GlaxoSmithKline Consumer Healthcare Supporting & Related Material Background Material 2011-03-24T04:00:00Z 2011 3     2019-02-05T13:00:37Z   0 0 0900006480c0c905
FDA-1977-N-0013-0041 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Final Monograph; Technical Amendment Rule Final Rule 2009-11-25T05:00:00Z 2009 11 2009-11-25T05:00:00Z   2019-02-22T12:55:02Z E9-28296 0 0 0900006480a5e8d7
FDA-1977-N-0013-0039 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Letter from CHPA to Michael S. Furness of Nonprescription Regulation Development, ONP, CDER/FDA Other Letter(s) 2009-08-27T04:00:00Z 2009 8 2009-08-27T04:00:00Z   2019-02-22T13:00:14Z   0 0 0900006480a1487c
FDA-1977-N-0013-0040 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Letter from CHPA to Ms. Arlene Solbeck, CDER/FDA Other Letter(s) 2009-08-27T04:00:00Z 2009 8 2009-08-27T04:00:00Z   2019-02-22T13:01:02Z   0 0 0900006480a14f53
FDA-1977-N-0013-0037 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Final Monograph; Corrections Rule Correction 2009-06-30T04:00:00Z 2009 6 2009-06-30T04:00:00Z   2019-02-21T21:46:48Z E9-15403 0 0 09000064809e636f
FDA-1977-N-0013-0038 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 List of References re: Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Final Monograph; Corrections Other List (LST) 2009-06-30T04:00:00Z 2009 6 2009-06-30T04:00:00Z   2019-02-21T21:50:59Z   0 0 09000064809e699e
FDA-1977-N-0013-0021 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Reference 3 - Comment No. EMC1 re: Background Material from FDA Supporting & Related Material Background Material 2009-04-29T04:00:00Z 2009 4     2019-02-06T12:47:24Z   0 0 0900006480828e3e
FDA-1977-N-0013-0018 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Public Administrative File - Organ-Specific Warnings: Internal Analgesic Antipyretic, and Antihreumatic Drug Products for Over-the Counter Human Use; Final Monograph - Memorandum Supporting & Related Material BKG-Background Material 2009-04-29T04:00:00Z 2009 4     2009-04-29T20:19:30Z   0 0 09000064808215d4
FDA-1977-N-0013-0019 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Reference 1 - Comment No. C7. re: Background Material from FDA Supporting & Related Material Background Material 2009-04-29T04:00:00Z 2009 4     2019-02-06T12:41:34Z   0 0 0900006480828df1
FDA-1977-N-0013-0026 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Reference 8 - Comment No. EC2 re: Background Material from FDA Supporting & Related Material Background Material 2009-04-29T04:00:00Z 2009 4     2019-02-05T16:16:09Z   0 0 0900006480828f68
FDA-1977-N-0013-0033 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Reference 22 - Green, J. L. et al., "Hepatic Function in Alcoholic Throughout 5 Days of Maximal Therapeutic Dosing of Acetaminophen (APAP)," Clinical Toxicology. 43:683, 2005. re: Background Material from FDA Supporting & Related Material Background Material 2009-04-29T04:00:00Z 2009 4     2019-02-05T16:48:10Z   0 0 0900006480829070
FDA-1977-N-0013-0030 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Reference 12 - Comment No. C8 re: Background Material from FDA Supporting & Related Material Background Material 2009-04-29T04:00:00Z 2009 4     2019-02-05T16:34:51Z   0 0 0900006480828faa
FDA-1977-N-0013-0027 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Reference 9 - Comment No. EREG1 re: background Material from FDA Supporting & Related Material Background Material 2009-04-29T04:00:00Z 2009 4     2019-02-06T12:56:30Z   0 0 0900006480828f78
FDA-1977-N-0013-0031 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Reference 56 - Eastern Research Group, Inc. "Cost Benefit Analysis of Proposed FDA Rule on Over-the-Counter Internal Analgesic, Antipyretic, and Antirheumatic Drug Products; Required Warnings," Final Report, October 6, 2004, with Addendum, July 30, 2007. re: Background Material from FDA Supporting & Related Material Background Material 2009-04-29T04:00:00Z 2009 4     2019-02-06T13:53:22Z   0 0 0900006480829222
FDA-1977-N-0013-0034 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Reference 23 -Dargere, S. et al., "Lack of Toxicity of Acetaminophen in Patients with Chronic Hepatitis C: A Randomized Controlled Trial," Gastroenterology. 118:A947, 2000 re: Background Material from FDA Supporting & Related Material Background Material 2009-04-29T04:00:00Z 2009 4     2019-02-06T13:05:17Z   0 0 090000648082907d
FDA-1977-N-0013-0022 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Reference 4 - Comment No. EREG4 re: Background Material Supporting & Related Material Background Material 2009-04-29T04:00:00Z 2009 4     2019-02-05T15:41:42Z   0 0 0900006480828e48
FDA-1977-N-0013-0020 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Reference 2 - Comment No. C3. re: Background Material from FDA Supporting & Related Material Background Material 2009-04-29T04:00:00Z 2009 4     2019-02-05T15:21:45Z   0 0 0900006480828e2b
FDA-1977-N-0013-0028 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Reference 10 - Comment No. C5 re: Background Material from FDA Supporting & Related Material Background Material 2009-04-29T04:00:00Z 2009 4     2019-02-05T16:24:22Z   0 0 0900006480828f8b
FDA-1977-N-0013-0035 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Reference 24 - "Action Plan for Liver Disease Research. A Report of the Liver Disease Subcommittee of the Digestive Diseases Interagency Coordinating Committee," NIH Publication No. 04-5491, 2004. re: Background Material from FDA Supporting & Related Material Background Material 2009-04-29T04:00:00Z 2009 4     2019-02-06T13:08:26Z   0 0 0900006480829082
FDA-1977-N-0013-0025 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Reference 7 - Comment No. EC1 re : Background Material from FDA Supporting & Related Material Background Material 2009-04-29T04:00:00Z 2009 4     2019-02-05T16:14:04Z   0 0 0900006480828eff
FDA-1977-N-0013-0029 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Reference 11 - Comment No. EC4 re: Background Material from FDA Supporting & Related Material Background Material 2009-04-29T04:00:00Z 2009 4     2019-02-05T16:33:06Z   0 0 0900006480828f97
FDA-1977-N-0013-0017 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Final Monograph Rule Final Rule 2009-04-29T04:00:00Z 2009 4 2009-04-29T04:00:00Z   2019-03-20T19:57:29Z E9-9684 0 0 090000648096ef53
FDA-1977-N-0013-0023 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Reference 5 - Comment No. C6 re: Background Material from FDA Supporting & Related Material Background Material 2009-04-29T04:00:00Z 2009 4     2019-02-05T16:04:41Z   0 0 0900006480828e54
FDA-1977-N-0013-0036 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Reference 49 - Comment No. C1 re: Background Material from FDA Supporting & Related Material Background Material 2009-04-29T04:00:00Z 2009 4     2019-02-05T17:45:03Z   0 0 09000064808291cf
FDA-1977-N-0013-0032 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Reference 56 - Eastern Research Group, Inc. "Cost Benefit Analysis of Proposed FDA Rule on Overthe-Counter Internal Analgesic, Antipyretic, and Antirheumatic Drug Products; Required Warnings," Final Report, October 6, 2004, with Addendum, July 30, 2007. re: Background Material from FDA (Part 2 of Reference 56) Supporting & Related Material Background Material 2009-04-29T04:00:00Z 2009 4     2019-02-06T14:05:23Z   0 0 0900006480829234
FDA-1977-N-0013-0024 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Reference 6 - Letter from Charles Ganley, FDA, to NSAID NDA Holders, July 2005 re: Background Material from FDA Supporting & Related Material Background Material 2009-04-29T04:00:00Z 2009 4     2019-02-06T12:51:03Z   0 0 0900006480828ea3
FDA-1977-N-0013-0011 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Submission Table of Contents re: Comment from McNeil Consumer Healthcare Supporting & Related Material Background Material 2008-11-07T05:00:00Z 2008 11     2019-03-20T14:08:38Z   0 0 09000064805d80b1
FDA-1977-N-0013-0010 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Background Material - BKG1 - References Supporting & Related Material BKG-Background Material 2008-11-07T05:00:00Z 2008 11     2008-11-07T20:29:50Z   0 0 09000064805d7f4a
FDA-1977-N-0013-0001 FDA Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN FDA-1977-N-0013 Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling Proposed Rule Notice of Proposed Rulemaking (NPRM) 2006-12-19T05:00:00Z 2006 12 2006-12-19T05:00:00Z 2007-06-20T03:59:59Z 2019-03-23T23:59:29Z E6-21855 0 0 09000064805d7f3f

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);